Welcome to IN166-Northwest Cancer Center in Valparaiso, IN, the latest site to activate TMIST in the last quarter.

Amendment #12
Amendment #12 of the TMIST protocol went into effect Nov. 8, 2023. This amendment includes reference to a new sub-study titled “Short-Term Image-Based Assessment of Breast Cancer Risk for Screening Mammography Utilizing TMIST,” which will utilize existing TMIST data in Appendix IV.

Help Us Increase TMIST Participants
Do you know of any sites interested in offering this trial to constituents, particularly those serving primarily Asian, Native American and Hispanic populations? If so, please forward this newsletter to your colleagues and instruct them to email [email protected] to learn about the study requirements, reimbursement/payment structure and how to start the application process. Deadline for new site activations for TMIST is July 1, 2024.

A Bright Spot in Efforts to Make Clinical Trials More Diverse
Black participation in TMIST continues to stand at about 21% — more than double the average Black participation rate in National Cancer Institute (NCI)-funded clinical trials (9%). In addition, TMIST leaders continue outreach efforts to assemble a diverse cancer screening trial population. Even as screening mammography volumes remain below pre-pandemic levels, TMIST enrollment soared past 80,000.

Reminder: TMIST Outreach Materials
In case you missed it, a variety of news stories about the trial, along with educational and recruitment materials, are posted on the ECOG-ACRIN website. Please check this website regularly for new materials and updates to existing resources. Also, please share these resources widely with potential enrollees, cancer research advocates and others in your community.

Blood and Buccal Collection Reminder
TMIST sites must collect blood and buccal samples from women who consent to provide them — as soon as possible after enrolling participants in TMIST, ideally at T0 — and develop a site plan for collection, processing and storing samples (prior login to your Cancer Therapy Evaluation Program (CTEP) — Identity and Access Management (IAM) account is required). Note the new deadline for blood and buccal sample collection introduced for participants enrolled under (and subsequent to) Amendment #9. The sample collection deadline remains the same for TMIST participants enrolled prior to Amendment #9 (i.e., no later than the T4 screening visit time point).

Physics QC Program
Compliance with the TMIST Physics Quality Control (QC) Program is now easier for U.S. sites that have complied with the TMIST QC for at least one year. If your site qualifies, you will no longer have to perform weekly, monthly or annual TMIST-specific QC on your TMIST-credentialed mammography systems. The TMIST Physics QC Team has notified sites that currently qualify. If you think your site qualifies but you have not received notification, email [email protected].

COVID-19 Vaccinations and Mammography
Some patients who receive COVID-19 vaccinations may temporarily develop benign swollen lymph nodes, which can show up on mammograms and other imaging tests. Please document the timing of each COVID-19 vaccination on visit forms, if not previously reported in Rave (login required).

Site Responsibilities for TMIST After Closing New Accruals
If your institution decides to close EA1151 to prospective enrollment, please remember your institution is still responsible for the following:

1. Continuing to manage all protocol assessments for subjects previously enrolled.
2. Maintaining IRB approval — whether NCI CIRB for U.S.-based sites or local IRB for international sites — of EA1151 throughout the entire protocol life cycle.
3. Meeting all future data submission requirements for subjects previously enrolled.
4. Submitting tissue, blood and buccal samples for women who consented.
5. Addressing any data management, central monitoring or audit queries.

These responsibilities remain with the enrolling institution until the study is added to the ECOG-ACRIN list of studies no longer requiring additional activities, or if all subjects are transferred to another site.

Full Study Closeout Requirements
Please note that full study closeout cannot occur at a site unless the following requirements are met:

1. Study has met its accrual goal or is closed for accrual at the Signatory Institution as well as at all Component and/or Affiliate Institutions relying on the Signatory Institution for this study.
2. All study participants have completed study interventions and follow-up activities — or — no study participants were enrolled.
3. No further research activity exists for this study (including recruitment, enrollment, data collection, data analysis and data submission).

Submit Pathology Materials After Breast Biopsy/Surgery
Please submit pathology reports, diagnostic pathology slides and tissue from breast biopsies/surgeries to the ECOG-ACRIN Central Biorepository and Pathology Facility as soon as your pathology department releases the materials. Access instructions on the EA1151 documents portal page (CTEP IAM account required).

Remote Consent Still Allowed for TMIST
Changes were made to section 2.3.8 of the CIRB Standard Operating Procedures (SOPs) to permit the use of remote consent outside of the COVID-19 public health emergency. These changes are summarized in the Summary of Changes to the SOPs. Please contact the NCI CIRB Help Desk via email at [email protected] with any questions.